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Diagnostic Test

Screening Tests for Anal Cancer (SWAN Trial)

N/A

Recruiting

Led By Elizabeth Chiao, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)

Aged 35 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

SWAN Trial Summary

This trialtests ways to detect early signs of anal cancer in HIV-negative women with a history of genital cancer.

Who is the study for?

This trial is for women under 45 years old who have had high-grade HPV-related diseases or non-metastatic cancers of the cervix, vagina, or vulva. They must be HIV-negative and treated within Mount Sinai Health System or Harris Health System in Houston. Participants need to understand English or Spanish.Check my eligibility

What is being tested?

The study is evaluating diagnostic tests used to screen for anal cancer precursors in women with a history of lower genital tract neoplasias and cancers but who do not have HIV.See study design

What are the potential side effects?

Since this trial involves diagnostic screening rather than medication, side effects are minimal but may include discomfort during testing procedures.

SWAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a high-grade HPV-related disease or non-spreading cancer in my genital area.

Select...

I am 35 years old or older.

SWAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity of anal cytology

Secondary outcome measures

Concordance of self- and clinician-collected PCR testing

Incidence of aHSIL at follow-up

Incidence of hrHPV, by type

+6 more

SWAN Trial Design

1Treatment groups

Experimental Treatment

Group I: Women With Prior HPV for Anal NeoplasiaExperimental Treatment1 Intervention

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER

933 Previous Clinical Trials

7,394,335 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,973 Previous Clinical Trials

1,789,046 Total Patients Enrolled

The University of Texas Health Science Center, HoustonOTHER

904 Previous Clinical Trials

320,660 Total Patients Enrolled

Media Library

Diagnostic tests for anal cancer screening (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05217940 — N/A

Anal Neoplasias Research Study Groups: Women With Prior HPV for Anal Neoplasia

Anal Neoplasias Clinical Trial 2023: Diagnostic tests for anal cancer screening Highlights & Side Effects. Trial Name: NCT05217940 — N/A

Diagnostic tests for anal cancer screening (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217940 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this clinical trial at present?

"Absolutely, info on clinicaltrials.gov confirms that the trial began recruitment of participants on March 2nd 2022 and was most recently updated October 19th 2022. It is expected to enroll 300 patients across 4 distinct locations."

Answered by AI

What is the current participant count for this medical experiment?

"Indeed, according to clinicaltrials.gov, this medical trial is now accepting new participants and has been since March 2nd 2022- the most recent update was on October 19th of that same year. 300 individuals are sought out at 4 different sites for participation in the project."

Answered by AI

Who else is applying?

What site did they apply to?

Medical University of South Carolina

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

ive been to other clinical trials with no help. Would finally like to be rid of this precancer condition from hpv that i have dealt with since i was 16.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Screening Women With Prior HPV for Anal Neoplasia

Keith M Sigel 2022. "Screening Women With Prior HPV for Anal Neoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05217940.

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